X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.
Researchers have assigned 1504 patients to Rivaroxaban ( Xarelto )( 20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min ) or dose-adjusted vitamin K antagonists ( VKAs ) in a 2:1 ratio.
Investigators selected either an early ( target period of 1-5 days after randomization ) or delayed ( 3-8 weeks ) cardioversion strategy.
The primary efficacy outcome was the composite of stroke, transient ischaemic attack ( TIA ), peripheral embolism, myocardial infarction, and cardiovascular death.
The primary safety outcome was major bleeding.
The primary efficacy outcome occurred in 5 ( two strokes ) of 978 patients ( 0.51% ) in the Rivaroxaban group and in 5 ( two strokes ) of 492 patients ( 1.02% ) in the VKA group [ risk ratio 0.50; 95% confidence interval (CI) 0.15-1.73 ].
In the Rivaroxaban group, four patients experienced primary efficacy events following early cardioversion ( 0.71% ) and one following delayed cardioversion ( 0.24% ).
In the VKA group, three patients had primary efficacy events following early cardioversion ( 1.08% ) and two following delayed cardioversion ( 0.93% ).
Rivaroxaban was associated with a significantly shorter time to cardioversion compared with VKAs ( P less than 0.001 ).
Major bleeding occurred in six patients ( 0.6% ) in the Rivaroxaban group and four patients ( 0.8% ) in the VKA group ( risk ratio, RR=0.76; 95% CI 0.21-2.67 ).
In conclusion, oral Rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion. ( Xagena )
Cappato R et al, Eur Heart J 2014; 35: 3346-3355